New depression combo therapy shows promise in large safety trial

NCT ID NCT05061719

Completed Symptom relief Sponsor: Intra-Cellular Therapies, Inc. Source: ClinicalTrials.gov ↗

First seen Nov 03, 2025 · Last updated May 01, 2026 · Updated 24 times

Summary

This study looked at whether adding lumateperone to standard antidepressants is safe for people with major depressive disorder. Over 800 adults who completed earlier studies took the drug for 26 weeks. The main goal was to track side effects, and researchers also measured changes in depression symptoms using a standard rating scale.

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Contacts and locations

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Locations

Clinical SIte

Torun, 87-100, Poland
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Phoenix, Arizona, 85012, United States
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Bentonville, Arkansas, 72712, United States
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Little Rock, Arkansas, 72211, United States
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Rogers, Arkansas, 72758, United States
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Culver City, California, 90230, United States
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Glendale, California, 91206, United States
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Newport Beach, California, 92660, United States
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Oceanside, California, 92056, United States
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Redlands, California, 92374, United States
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Riverside, California, 92506, United States
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San Diego, California, 92103, United States
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Sherman Oaks, California, 91403, United States
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Temecula, California, 92951, United States
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Upland, California, 91786, United States
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Fort Lauderdale, Florida, 33319, United States
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Jacksonville, Florida, 32256, United States
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Orlando, Florida, 32801, United States
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Palm Bay, Florida, 32905, United States
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West Palm Beach, Florida, 33407, United States
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Atlanta, Georgia, 30328, United States
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Atlanta, Georgia, 30329, United States
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Atlanta, Georgia, 30331, United States
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Decatur, Georgia, 30030, United States
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Joliet, Illinois, 60435, United States
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Overland Park, Kansas, 66211, United States
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Gaithersburg, Maryland, 20877, United States
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Boston, Massachusetts, 02131, United States
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Flowood, Mississippi, 39232, United States
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Saint Charles, Missouri, 63304, United States
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Berlin, New Jersey, 08009, United States
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Toms River, New Jersey, 08755, United States
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Brooklyn, New York, 11235, United States
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Cedarhurst, New York, 11516, United States
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Mount Kisco, New York, 10549, United States
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Charlotte, North Carolina, 28211, United States
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Allentown, Pennsylvania, 18104, United States
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Media, Pennsylvania, 19063, United States
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Plymouth Meeting, Pennsylvania, 19462, United States
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Austin, Texas, 78737, United States
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Bellevue, Washington, 98007, United States
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Burgas, 8001, Bulgaria
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Kazanlak, 6100, Bulgaria
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Novi Iskar, 1282, Bulgaria
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Pleven, 5809, Bulgaria
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Plovdiv, 4004, Bulgaria
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Rousse, 7003, Bulgaria
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Sofia, 1408, Bulgaria
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Sofia, 1680, Bulgaria
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Targovishte, 7700, Bulgaria
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Tsarev Brod, 9747, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Veliko Tarnovo, 5047, Bulgaria
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Vratsa, 3001, Bulgaria
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Brno, 60200, Czechia
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Hostivice, 253 01, Czechia
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Ostrava, 708 00, Czechia
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Pilsen, 301 00, Czechia
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Prague, 100 00, Czechia
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Prague, 160 00, Czechia
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Prague, 186 00, Czechia
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Helsinki, 00100, Finland
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Oulu, 90100, Finland
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Bad Homburg, 61348, Germany
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Freiburg im Breisgau, 79104, Germany
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Hamburg, 20253, Germany
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Mittweida, 09648, Germany
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Schwerin, 19053, Germany
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Westerstede, 26655, Germany
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Budapest, 1033, Hungary
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Budapest, 1083, Hungary
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Budapest, 1134, Hungary
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Budapest, 1135, Hungary
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Debrecen, 4032, Hungary
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Gyöngyös, 3200, Hungary
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Guwahati, Assam, 781010, India
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Ahmedabad, Gujarat, 380013, India
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Jūnāgadh, Gujarat, 362001, India
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Vadodara, Gujarat, 390021, India
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Mysore, Karnataka, 570001, India
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Aurangabad, Maharashtra, 431005, India
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Nagpur, Maharashtra, 440010, India
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Nashik, Maharashtra, 422001, India
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Mumbai, 400008, India
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Nashik, 422005, India
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Bełchatów, 97-400, Poland
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Bialystok, 15-404, Poland
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Bialystok, 15-464, Poland
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Bialystok, 15-879, Poland
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Bydgoszcz, 85-080, Poland
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Gdansk, 80-546, Poland
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Gorlice, 38-300, Poland
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Leszno, 64-100, Poland
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Pruszcz Gdański, 83-000, Poland
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Wroclaw, 50-414, Poland
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Bratislava, 82007, Slovakia
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Košice, 04001, Slovakia
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Rimavská Sobota, 979 01, Slovakia
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Svidník, 089 01, Slovakia
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Vranov nad Topľou, 09301, Slovakia
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Zlaté Moravce, 953 01, Slovakia
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Ansan-si, North Chungcheong, 15355, South Korea
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Gwangju, 61469, South Korea
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Seoul, 01830, South Korea
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Seoul, 03080, South Korea
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Seoul, 06351, South Korea
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Lund, 22222, Sweden
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Stockholm, 11329, Sweden
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Brno, 615 00, Czechia

Conditions

Explore the condition pages connected to this study.

MAJOR DEPRESSIVE DISORDER